study the various regional anesthetic technique to reduce the pain of thoracotomy after cardiac surgery in children.

Completed

• Conditions: Patent ductus arteriosus,

• Registration Number: CTRI/2018/01/011559
• Lead Sponsor: Department of Cardiac Anesthesia

Brief Summary

All preoperative cardiacmedication will be continue until the morning of surgery. Premedication willconsist of 0.1 mg/kg morphine and 0.5 mg/kg promethazine intramuscularly 1 hourbefore the surgery. After coming to operative room, initial monitoring willinclude a 5-lead electrocardiogram, Noninvasive blood pressure, and pulseoxymetry. Anesthetic induction will performed with Sevoflurane with oxygen andair, 50% each. Anesthesia will supplemented with intravenous midazolam, 0.05 to0.1 mg/kg; fentanyl 2 mcg/kg and rocuroneum 0.8 mg/kg. The maintenance will beachieved with midazolam, fentanyl, sevoflurane and atracurium as required.

Following measurements will be obtained for eachpatient. The hemodynamic parameters – Heart rate and Blood pressure (Systolic,Diastolic and mean) will be measured as baseline, after induction ofanaesthesia. Intraoperative monitoring will be continued. After completion ofsurgery and administering the block, hemodynamic parameters noted and patientwill be shifted to ICU with endotracheal tube in situ. Extubation time,monitoring of pulse rate, blood pressure SpO2, ECG, Respiratory rate and Modifiedobjective pain score (MOPS) will be recorded in ICU for 12 hours after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-11
• Study Completion: 2018-06-30
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Pediatric patients between age 1 to 14 years, ASA Grade I or II with congenital heart disease i.e. Patent ductus arteriosus (PDA), Coarctation of Aorta (CoA), Atrial Septal defect (ASD), Partial anomalous pulmonary venous return (PAPVR) and Blalog taussig shunt (B T shunt) requiring elective thoracotomy for surgical correction or repair.

Exclusion Criteria

Children requiring sternotomy for correction of heart defect, children with emergency cardiac surgery, children having deranged coagulation profile and children with previous thoracotomy will be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of post operative analgesia and duration of post operative analgesia by Modified Objective Pain Score (MOPS) between serratus anterior plane block (SAPB), Intercostal nerve block (ICNB), and pectoral nerves (PECS) 1 block in pediatric patients undergoing a thoracotomy.	After completion of surgery and administering the block, hemodynamic parameters noted and patient will be shifted to ICU with endotracheal tube in situ. Extubation time, monitoring of pulse rate, blood pressure SpO2, ECG, Respiratory rate and Modified objective pain score (MOPS) will be recorded in ICU every 2 hours interval for upto 12 hours after extubation.

Secondary Outcome Measures

Name	Time	Method
To compare the side effect or complications, rescue analgesia (fentanl) consumption, associated with the three procedures.	After completion of surgery and administering the block, hemodynamic parameters noted and patient will be shifted to ICU with endotracheal tube in situ. Extubation time, monitoring of pulse rate, blood pressure SpO2, ECG, Respiratory rate and Modified objective pain score (MOPS) will be recorded in ICU every 2 hours interval for upto 12 hours after extubation.

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr Sandeep Chauhan

Principal investigator

9868398101

sdeep61@gmail.com